Deeming Regulations: Important Deadlines in 2016

The FDA’s proposed deeming regulations extend the FDA’s regulatory authority to additional tobacco products including e-cigarettes, e-liquids, cigars, hookah tobacco, pipe tobacco and dissolvables, referred to as “covered tobacco products.” The FDA currently regulates cigarette tobacco, roll-your own, cigarettes, and smokeless tobacco. Once the deeming regulations are effective, manufacturers, retailers, importers and distributors should ensure that they are ready to meet the new deadlines. While there has been much focus on the longer-term premarket review requirements and packaging changes, there are several important deadlines to note for the remainder of 2016.

Effective August 8, 2016:

Retailers may only sell the covered tobacco products to customers aged 18 or older and they must check the photo of all customers under age 27.

Retailers, manufacturers, importers, and distributors may not give away free samples of the covered tobacco products.

Retailers may not sell covered tobacco products in a vending machine.

Retailers, manufacturers, importers, and distributors are prohibited from introducing into interstate commerce modified risk tobacco products (other than those with the descriptors “low”, “light”, and “mild”) without a modified risk order in effect.

This is the cut-off date for products in interstate commerce which will be required to file ingredient listings in 2017. (Those products that are not in market as of August 8, 2016 will require an ingredient listing 90 days prior to introduction.) This is also the cut-off date for introducing new products without premarket approval from the FDA.

Effective August 20, 2016:

Domestic manufacturers and importers of cigars and pipe tobacco must report data to enable FDA to calculate tobacco “user fees” no later than this date.

Effective December 31, 2016:

Manufacturers and importers, including those who repackage or change the container (i) must register the establishments engaged in the manufacture, preparation, compounding, or processing of a tobacco product, and (ii) file product listings. This will be subject to future guidance from the FDA.

Failure to comply with these requirements may render a covered tobacco product adulterated, misbranded, or both, and it is unlawful for any entity to sell or distribute an adulterated and/or misbranded product in interstate commerce.

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